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NCT ID: NCT05253976 Withdrawn - Clinical trials for Rheumatoid Arthritis

PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

Start date: September 1, 2022
Phase:
Study type: Observational

The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the NexGen TM Augmentation Patella. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.